BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW RA CATH SET: 20 GA X 1-3/4IN

    MDR report key: 24801341 · Received April 7, 2026

    Report

    Report Number
    9680794-2026-00255
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    December 18, 2025
    Report Date
    March 13, 2026
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    OFB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE WIRE WAS FOUND KINKED." THE DEVICE WAS CONSIDERED UNUSABLE AND WAS REPLACED WITH A NEW DEVICE. THIS WAS FOUND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859600 ARROW RA CATH SET: 20 GA X 1-3/4IN WIRE GUIDE CATHETER OFB ARROW INTERNATIONAL LLC 14F19M0253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED.